Disposable Automatic Core Biopsy Instrument
Summary
Suzhou Leapmed Healthcare Corporation received 510(k) clearance for Disposable Automatic Core Biopsy Instrument, a KNW device. Cleared on 2021-11-10.
Details
Source
510(k) Clearance
External ID
K212284
Action Date
2021-11-10
Status
Traditional
Category
device
Product Code
KNW
Product Description
Disposable Automatic Core Biopsy Instrument. Product code: KNW.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Suzhou Leapmed Healthcare Corporation has received 4 total clearances in our database.
Suzhou Leapmed Healthcare Corporation has 4 FDA actions in our database, including 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Suzhou Leapmed Healthcare Corporation have FDA actions?
Suzhou Leapmed Healthcare Corporation has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212284" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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